UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043983
Receipt number R000050233
Scientific Title Exploratory study about changes of oral hygiene condition by eating the food containing aroma component in dementia patients
Date of disclosure of the study information 2021/04/21
Last modified on 2021/04/20 15:24:03

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Basic information

Public title

Exploratory study about changes of oral hygiene condition by eating the food containing aroma component in dementia patients

Acronym

Exploratory study about changes of oral hygiene condition by eating the food containing aroma component in dementia patients

Scientific Title

Exploratory study about changes of oral hygiene condition by eating the food containing aroma component in dementia patients

Scientific Title:Acronym

Exploratory study about changes of oral hygiene condition by eating the food containing aroma component in dementia patients

Region

Japan


Condition

Condition

Dementia patients

Classification by specialty

Geriatrics Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effects of the food containing aroma component intake on oral hygiene condition in dementia patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Total number of oral bacteria

Key secondary outcomes

(1) Number of oral opportunistic pathogen
(2) Number of oral periodontal bacteria
(3) Oral hygiene conditions (tongue coating, bad breath, etc.)
(4) Prevalence (fever, pneumonia, etc.)
(5) Doctor's opinion


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

The food containing aroma component

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) 65 years of age or older
(2) Male and Female
(3) Dementia
(4) Diagnosed by a physician or a speech therapist as being capable of feeding training with food (in the case of tube feeding)

Key exclusion criteria

(1) Severe disease
(2) Difficulty with Swallowing
(3) Not permitted to join the study by doctors

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Michiko
Middle name
Last name Obara

Organization

Gifu Pharmaceutical University

Division name

Community Healthcare Pharmacy

Zip code

501-1196

Address

1-25-4 Daigakunishi, Gifu, Japan

TEL

058-230-8100

Email

obara@gifu-pu.ac.jp


Public contact

Name of contact person

1st name Michiko
Middle name
Last name Obara

Organization

Gifu Pharmaceutical University

Division name

Community Healthcare Pharmacy

Zip code

501-1196

Address

1-25-4 Daigakunishi, Gifu, Japan

TEL

058-230-8100

Homepage URL


Email

obara@gifu-pu.ac.jp


Sponsor or person

Institute

Community Healthcare Pharmacy, Gifu Pharmaceutical University

Institute

Department

Personal name



Funding Source

Organization

UHA Mikakuto Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Medical Corporation Toujinkai Fujitate Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Japan Association of Health care Initiative

Address

1-15-10, Toranomon, Minato-ku, Tokyo

Tel

03-5157-3341

Email

info@jahi.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

医療法人藤仁会 藤立病院(大阪府)


Other administrative information

Date of disclosure of the study information

2021 Year 04 Month 21 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2020 Year 11 Month 11 Day

Date of IRB

2020 Year 11 Month 13 Day

Anticipated trial start date

2021 Year 04 Month 21 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 04 Month 20 Day

Last modified on

2021 Year 04 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050233


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name